Regulatory Biomedical Engineering (rBME)
The Master of Engineering in Regulatory Biomedical Engineering (rBME) is an interdisciplinary program offered through the Department of Biomedical Engineering in partnership with GW's School of Medicine and Health Sciences. The new program addresses an unmet need for a graduate program to train engineers in the specific set of skills of regulatory science, biomedical innovation, and entrepreneurship.
Students with training in engineering or physics and/or relevant industry/government experience study the fundamentals of biomedical engineering, global regulatory affairs, regulatory strategy in the development of devices and diagnostics, regulatory compliance, engineering patent law, medical measurements, and instrument design.
In addition to coursework, students gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.
The rBME program is 30 credit hours distributed across four areas:
- Biomedical engineering coursework and practicum (12 credits)
- Regulatory issues (9 credits)
- Patent law for engineers (3 credits)
- Targeted electives from various disciplines (6 credits)
Students will require 12-24 months or 3 semesters for completion.
Students who complete the Master of Engineering in Regulatory Biomedical Engineering acquire skill sets comparable to those of an engineer with five to seven years of experience, making them competitive in the medical device or imaging industries. Graduates will be equipped to provide in-house regulatory expertise to device companies, or join government regulatory and compliance institutions.
Applicants to the rBME program must adhere to the standard admissions requirements for master's students.
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